The Medicine Amendment Act, 2008 will come into operation on 1 June 2017.

This piece of legislation enacts restrictions and requirements around the manufacture, importation, sale and use of all medical devices and IVDs.

Definition: ‘IVD’ (in vitro diagnostic medical device)

means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes;

Definition of ‘medical device’

means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article—

  • (a) intended by the manufacturer to be used, alone or in combination,
    for human beings for—

    • (i) diagnosis, prevention, monitoring, treatment or alleviation of disease;
    • (ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
    • (iii) investigation, replacement, modification or support of the anatomy or of a physiological process;
    • (iv) supporting or sustaining life;
    • (v) control of conception;
    • (vi) disinfection of medical devices; or
    • (vii) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and
  • (b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means;

Date: August 24, 2017

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